LONG-TERM OUTCOMES of COVID-19 VACCINATION in PATIENTS with RARE and COMPLEX CONNECTIVE TISSUE DISEASES: AN AD-INTERIM ANALYSIS of ERN-RECONNET VACCINATE STUDY

Background: Since the COVID-19 vaccination campaign was launched all over Europe, there has been general agreement on how benefts of SARS-CoV2 vaccines outweigh the risks in patients with rare connective tissue diseases (rCTDs). Yet, there is still limited evidence regarding safety and efficacy of such vaccines in these patients, especially in the long-term. For this reason, in the framework of ERN-ReCONNET, an observational long-term study (VACCINATE) was designed in order to explore the long-term outcome of COVID-19 vaccination in rCTDs patients. The consent form was developed thanks to the involvement of the ERN ReCONNET ePAG Advocates (European Patients Advocacy Group). Objectives: To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and the potential impact on disease activity. Primary endpoints were the prevalence of adverse events (AEs) and of disease exacerbations post-vaccination. Secondary endpoints were the proportion of serious adverse events (SAEs) and adverse events of special interest for COVID-19 (adapted from https://bright-oncollaboration.us/wp-content/uploads/2021/01/SO2-D2.1.2-V1.2-COVID-19- AESI-update-23Dec2020-review-fnal.pdf) Methods: The frst ad-interim analysis of the VACCINATE study involved 9 ERN-ReCONNET Network centres. Patients over 18 years of age with a known rCTD and who received vaccine against COVID-19 were eligible for recruitment. Demographic data and diagnoses were collected at the time of enrolment, while the appearance of AEs and potential disease exacerbations were monitored after one week from each vaccination dose, and then after 4, 12 and 24 weeks from the second dose. A disease exacerbation was defned as at least one of the following: new manifestations attributable to disease activity, hospital-ization, increase in PGA from previous evaluation, addition of corticosteroids or immunosuppressants. Results: A cohort of 300 patients (261 females, mean age 52, range 18-85) was recruited. Systemic lupus erythematosus (44%) and systemic sclerosis (16%) were the most frequent diagnoses, followed by Sjogren's syndrome (SS,12%), idiopathic infammatory myositis (IMM,10%), undifferentiated connective tissue disease (UCTD,8%), mixed connective tissue disease (MCTD,4%), Ehlers-Dan-los's syndrome (EDS,4%), antiphospholipid syndrome (APS,2%). AEs appearing 7 days after the frst and second doses were reported in 93 (31%) and 96 (32%) patients respectively, mainly represented by fatigue, injection site reaction, headache, fever and myalgia. Otitis, urticaria, Herpes Simplex-related rash, stomatitis, migraine with aura, vertigo, tinnitus and sleepiness were reported with very low frequency. Less than 2% of patients experienced AEs within 24 weeks from the second dose. No SAEs or AEs of special interest were observed in the study period. There were 25 disease exacerbations (8%), 7 of which severe. The highest number of exacerbations was observed after 4 weeks from the second dose (12 within week 4, 6 within week 12 and 7 within week 24). Disease exacerbation was most frequent in patients with EDS (33%) and MCTD (25%). Conclusion: This preliminary analysis shows that COVID-19 vaccination is safe in rCTDs patients. AEs appear most often early after vaccination and are usually mild. Disease exacerbations are not frequent, but can be potentially severe and tend to occur most frequently within the frst month after vaccination. Exacerbations can also occur 3-6 months after vaccination, although a causal relationship with the vaccination remains to be established. Our present data underline the importance of long-term observational studies.

Psychological well-being in cancer outpatients during COVID-19

Purpose: The psychological status of cancer outpatients receiving anti-neoplastic treatment during the lockdown in a Italian non-COVID Cancer Center, was been investigated with the following aims: to measure the levels of post-traumatic stress symptoms, depression and anxiety;to compare patients with different cancer sites;to compare the anxiety and depression levels measured in this emergency period between cancer and non-cancer patients and between cancer patients before and after the emergency. Methods: The following questionnaires were used: The Hospital Anxiety and Depression Scale (HADs) and the Impact of Event Scale-Revised (IES-R).Worries regarding the COVID-19 on patients' lives, socio-demographic and clinical details were collected using a brief structured questionnaire. Results: One-hundred seventy-eight outpatients were enrolled. We found that 55% of patients were above the cut-off for HADS general scale and 23.7% had severe level of PTSD. The 68% of patients declared that their worries have increased during the pandemic especially for women. Patients with lung cancer have higher general distress compared with patients with breast cancer and lymphoma. The non cancer sample had values significantly higher both for the IES-R scales and for HADS Depression subscale. Finally, cancer patients who experienced the health emergency showed higher levels of anxiety than those measured 2 years ago. Conclusion: Cancer out-patients of the present sample have severe post-traumatic stress symptoms and psychological distress, those with lung cancer are at higher risk and may need special attention. Non-oncological subjects have higher depression levels than cancer patients.

FP06.04 Psychological Distress in Outpatients with Lymphoma, Lung and Breast Cancer during COVID-19 pandemic

Introduction: The psychological impact of the lockdown experienced during the COVID-19 pandemic has been found detrimental for the general population, but it has still not been evaluated in cancer patients. We have investigated the psychological status of outpatients receiving anti-neoplastic treatmentduring the lockdown in a non-COVID Cancer Center, with the following aims: to measure the levels of post-traumatic stress symptoms, depression and anxiety, to compare patients with different diagnosis. A further objective was to compare the anxiety and depression levels between cancer patients before and after the emergency assuming an increase in distress in cancer patients in this period due to the health emergency. Methods: Outpatients attending the IRCCS "Giovanni Paolo II" in Bari for their therapy were asked to complete these questionnaires: The Hospital Anxiety and Depression Scale (HADs) and the Impact of Event Scale-Revised (IES-r).Worries regarding the COVID-19 on patients’ lives, socio-demographic and clinical details were investigated using a brief structured questionnaire. Results: One-hundred seventy-six outpatients (n.59 with lung cancer, n.40 with breast cancer, n.77 with lymphoma) were enrolled. Mean age was 57.9 y.o. (SD ±14);48% were male. We found that 54,4% of patients were above the cut-off (score≥16) for HADS general scale. The mean-IES-R score of patients was 25 (SD±17), with 22.8% indicating severe level of PTDS. The HADS-D has been found significantly correlated with IES-R (r= 0.35;p<0.005). The 70% of patients declared that their worries have increased during the pandemic;their bigger concerns were: the risk of getting infected while at hospital (51.4%);the risk of infecting relatives coming back home (38.7%), andthe risk of delaying therapy (35.3%).When comparing the level of anxiety and depression in different diagnosis it has been found that patients with lung cancer have higher distress(HADs-general scale) than patients with lymphoma (F=17.3, p<0.005) and breast cancer (F=8.86, p<0.005). Finally, cancer patients who experienced the health emergency showed higher levels of anxiety Hads-A, t (237) = 3.73 p<0.001), and general distress (Hads-G, t (237) = 2.51) than those measured 2 years ago (fig 1). Conclusion: This study focused on the psychological aspects of cancer patients during the COVID-19 pandemic, finding that one quarter of patients has severe post-traumatic stress symptoms, and has psychological distress. Patients with lung cancer have higher distress compared to the other groups. This condition risks being overlooked by clinical concerns, so we underline the importance to place even more attention to the psychological needs of patients. Keywords: cancer, COVID, Psychological distress

P40.01 Tobacco use in Adolescence and Associated Factors: Products, School, Family, Peers and Movies in Pandemic Period

Introduction: Tobacco smoking among adolescents is still frequent and stalling in the last decades, so the main purpose of this research is to know if the COVID-19 pandemic had an impact on adolescents' perceptions regarding smoking. We investigated: 1) the prevalence of active cigarette smoking;2) if smoking of parents and friends and school environment influences the choice to smoke;3) if the students capture the presence of images of smoking in films;4) the level of concern of the younger people regarding the association between Covid-19 disease and smoke. Methods: 719 students (65% boys, aged 13-19 years, from the high school, technical and professional institutes) filled an anonymous questionnaire (31-item), during Covid-lockdown. Results: The students have been subdivided into the following categories: daily smokers (12.8%), occasional (30.3%), former (8.8%) and never smokers (48.1%). 52% of students have smoked at least once (n.s. for gender). Interestingly, over time the probability of starting to smoke decreases (fig1). Furthermore, the students who start smoking early tend to smoke daily (r=-0.13;p < 0.01) and more cigarettes (r=-0.30;p < 0.01). 83% of students start smoking out of curiosity and a spirit of adventure, consuming 1 to 4 cigarettes daily. Moreover 30% of them would want to quit but failed;27% never thought about it;while 44% report that they will quit smoking in a few years. 59% consume manufactured cigarettes, 36% smoke rolling tobacco;3% use HNB and 2% e-cigarettes. The type of cigarettes considered less harmful are electronic cigarettes. 68% of the student smokers have in turn someone in the family who smokes, on the contrary only 37.5% of non-smoking students have parent smokers. Considering only the students who smoked at least once, 65% replied that someone among friends smoke, while only 4% of no-smokers have smoking friends. Finally, the adolescents attending professional institutes smoke daily and more cigarettes (F (2, 368)=5.32;p<0.05) compared to the other. Moreover, it emerged that 48% do not pay attention to smoking scenes in the movies. About the coronavirus epidemic, 80% reported a upper-middle concern and 84% think that is very dangerous for smokers, while 76,3% consider that the respiratory symptoms of smokers Covid-19 patients could have a worse outcome and that being a smoker can become very dangerous for the clinical complications that can occur (84%). [Formula presented] Conclusion: These data, even more meaningful during COVID-19 pandemic, highlight the importance and the need of primary prevention as well as of suitable secondary prevention programs. Keywords: Tobacco use, adolescents, Pandemic period

Psychological distress in outpatients with lymphoma, lung and breast cancer during covid-19 pandemic

Background: The psychological impact of the lockdown experienced during the COVID-19 pandemic has been found detrimental for the general population, but it has still not been evaluated in cancer patients. We have investigated the psychological status of outpatients receiving anti-neoplastic treatmentduring the lockdown in a non-COVID Cancer Center, with the following aims: to measure the levels of post-traumatic stress symptoms, depression and anxiety, to compare patients with different diagnosis. An additional aim was to offer a psychological on-line support to patients who need it. Material and methods: Outpatients attending the IRCCS 'Giovanni Paolo II' in Bari for their therapy were asked to complete these questionnaires: The Hospital Anxiety and Depression Scale (HADs) and the Impact of Event Scale-Revised (IES-r).Worries regarding the COVID-19 on patients' lives, socio-demographic and clinical details were investigated using a brief structured questionnaire. Results: One-hundred seventy-six outpatients (n.59 with lung cancer, n.40 with breast cancer, n.77 with lymphoma) were enrolled. Mean age was 57.9 y.o. (SD ±14);48% were male. We found that 54,4% of patients were above the cut-off (score≥16) for HADS general scale. The mean-IES-R score of patients was 25 (SD±17), with 22.8% indicating severe level of PTDS. The HADS-D has been found significantly correlated with IES-R (r= 0.35;p<0.005). The 70% of patients declared that their worries have increased during the pandemic;their bigger concerns were: the risk of getting infected while at hospital (51.4%);the risk of infecting relatives coming back home (38.7%), andthe risk of delaying therapy (35.3%).When comparing the level of anxiety and depression in different diagnosis it has been found that patients with lung cancer have higher distress(HADs-general scale) than patients with lymphoma (F=17.3, p<0.005) and breast cancer (F=8.86, p<0.005). Conclusions: This study focused on the psychological aspects of cancer patients during the COVID-19 pandemic, finding that one quarter of patients has severe post-traumatic stress symptoms, and has psychological distress. Patients with lung cancer have higher distress compared to the other groups. This condition risks being overlooked by clinical concerns, so weunderline the importance to place even more attention to the psychological needs of patients, especially for those who have symptoms similar to COVID-19 as in lung cancer, in order to offer adequate support.